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Study Manager

Fort Worth Metro Area, TX

Post Date: 03/09/2017 Job ID: JN -032017-18569
Oversees all aspects of clinical supplies management ensuring there are sufficient supply levels at sites and depots
Represents clinical supplies function at clinical trial team meetings; communicates plan and timelines to internal and external customers and partners.
Reviews clinical trial protocol and provides input to clinical supplies and IRT sections.
Creates forecasts and packaging design based on study needs to ensure optimized supply plan in terms of cost, feasibility and overage
Proactively drives the labeling, packaging, release, distribution and return of clinical supplies for assigned studies, ensuring the project timeline is met or exceeded.
Participates in cross functional teams and provides guidance on best practices for clinical supplies management.
Leads process improvement initiatives and training efforts as a clinical supplies SME
Supports internal/external inspections and audits
Maintains required documents in a manner consistent with cGMP, 21 CFR Part 11, Annex 13 as well as internal QM, Corporate and Functional level SOPs.

Proficiency in the design and use of Interactive Response Technology
Project management and process improvement experience
Minimum 5-7 years of experience managing clinical supplies or relevant experience
Proven leadership behaviors and strong communication skills
Medical Device experience a plus
Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements
PMP certification is preferred

Bachelor s degree require
Master s degree is a plus

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